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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12616001565437 |
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Date of registration:
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11/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Improved near visual acuity in presbyopes using carbachol and brimonidine eye drops.
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Scientific title:
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Clinical outcomes of combined versus separate carbachol and brimonidine drops in correcting presbyopia |
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Date of first enrolment:
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10/02/2016 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12616001565437.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
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Phase:
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Phase 2 / Phase 3
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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A/Prof Almamoun Abdelkader
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Address:
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Saudi German Hospital, King Fahad Road, Khamis Mushait, Aseer, Kingdom of Saudi Arabia, P.O Box 2355.
Saudi Arabia |
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Telephone:
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+966557797107 |
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Email:
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mamounkader@gmail.com |
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Affiliation:
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Name:
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A/Prof Almamoun Abdelkader
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Address:
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Saudi German Hospital, King Fahad Road, Khamis Mushait, Aseer, Kingdom of Saudi Arabia, P.O Box 2355.
Saudi Arabia |
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Telephone:
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+966557797107 |
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Email:
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mamounkader@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria were as follows: age between 42 and 58 years, emmetropia [cycloplegic spherical equivalent (SE), +/-0.25 D; astigmatism "equal to" or less than 0.25 D] and binocular uncorrected distance visual acuity "equal to" or greater than 20/20
Exclusion criteria: Exclusion criteria concerned patients with myopia, hyperopia and astigmatism higher than 0.25 diopter as well as those with corneal, lens and vitreous opacities, pupil irregularities, anisocoria, amblyopia, chronic general pathologies and medications that would interact unfavorably with carbachol and brimonidine
Age minimum:
42 Years
Age maximum:
58 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Eye - Normal eye development and function
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presbyopia;
presbyopia
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Intervention(s)
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One drop was administrated per application to the on-dominant eye by the primary investigator who is an ophthalmologist. Each participant received three treatments to the non-dominant eye - 3% carbachol and 0.2% brimonidine in both combined and separate forms, carbachol only, and brimonidine only. It is a cross-over trial, so that, the washout period was one week.
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Primary Outcome(s)
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Near visual acuity (NVA) was assessed at 40 cm using a hand-held Rosenbaum chart with Jaeger notation, always employing the same luminosity of 160 cd/m2. [1,2,4 and 8 hours post drug administration ]
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Secondary Outcome(s)
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Pupil size (PS) was measured using Colvard handheld Infrared pupillometer (Oasis Medical, Glendora, CA, USA).[1,2,4 and 8 hours post drug administration.]
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Source(s) of Monetary Support
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Almamoun Abdelkader is funding the study from his own personal funds
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Ethics review
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Status: Approved
Approval date:
Contact:
Abha ethics committee eye centre and research
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Status: Approved
Approval date:
Contact:
The RCRC Independent Review Board, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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